Emergency Access to Remdesivir Outside of Clinical Trials
Remdesivir is an investigational drug that has not been approved by any regulatory authority, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet known. Enrollment in clinical trials is the primary way to access remdesivir to generate critical data that inform the appropriate use of remdesivir. We recognize that enrollment in clinical trials is not feasible for all patients, and in consultation with regulatory authorities, we have implemented programs that are designed to provide emergency treatment access for patients with severe clinical manifestations of COVID-19.
Individual compassionate use requests continue to be reviewed for pregnant women and children less than 18 years of age with confirmed COVID-19 and severe manifestations of disease.
Beyond these two populations, Gilead has transitioned the provision of emergency access to remdesivir from individual compassionate use requests to expanded access programs. Our goals with this transition were to manage the volume of requests, expedite the delivery of the drug for patients and enable the gathering of appropriate data.
Expanded access programs are now operational in the United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, the Netherlands, Romania, Spain, Switzerland and the UK. Programs in other countries are currently under rapid development in conjunction with national regulatory authorities worldwide.
Over time, the expanded access program in the United States will wind down, as the U.S. Food and Drug Administration (FDA) has authorized the emergency use of remdesivir to treat hospitalized adult and pediatric patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. The FDA’s Emergency Use Authorization will enable appropriate patients to more readily access remdesivir at this time, due to the public health emergency. Remdesivir has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. For information about the authorized use of remdesivir and mandatory requirements of the EUA in the United States, please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorization.
Remdesivir Clinical Trials
The remdesivir clinical trial program was designed to answer multiple scientific questions in parallel, to rapidly evaluate the potential for remdesivir to treat COVID-19 patients.
we are conducting two randomized, open-label, multicenter, Phase 3 clinical studies to evaluate the safety and efficacy of two dosing durations – 5 days and 10 days – of remdesivir in adults diagnosed with COVID-19.
The first of the two SIMPLE studies evaluated the safety and efficacy of both 5-day and 10-day dosing durations of remdesivir, in patients with severe COVID-19. The study initially enrolled 400 patients and subsequently allowed for the enrollment of 5,600 additional patients, including those on mechanical ventilation, in an expansion phase of the study. Topline results from the initial study phase were announced on April 29, and the full results from the initial phase were published in The New England Journal of Medicine on May 27. Data from the expansion phase of the study are expected in the near future.
The second SIMPLE study is evaluating the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir, compared with standard of care alone, in patients with moderate COVID-19. This study initially enrolled 600 patients and subsequently allowed for the enrollment of 1,000 additional patients in an expansion phase of the study. Topline results from the initial study phase were announced on June 1.
we are conducting a Phase 2/3 clinical trial that will investigate the use of remdesivir in treating pediatric patients with COVID-19. The study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of remdesivir in a younger population hospitalized with the virus, including newborns through adolescents. The single-arm, open-label study will enroll approximately 50 patients under the age of 18, beginning in June. Patients will be treated for up to 10 days, with dosing determined based on age and weight.
we are working in collaboration with Roche to evaluate the safety and efficacy of remdesivir in combination with tocilizumab, an anti-inflammatory drug, compared to remdesivir plus placebo in patients with severe COVID-19 pneumonia. The Phase 3, double-blind, placebo-controlled trial is expected to begin enrolling in June, with a target of approximately 450 patients globally.
The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, conducted a Phase 2 adaptive, randomized, double-blind, placebo-controlled trial evaluating remdesivir as a potential treatment for hospitalized adult patients diagnosed with COVID-19. Gilead provided study drug at no charge and provided input on study design and conduct. The study enrolled 1,063 participants at 47 U.S. and 21 international sites. Preliminary findings were announced on April 29 and the full data were published in The New England Journal of Medicine on May 22.
NIAID is conducting a second adaptive trial with remdesivir. The Phase 3, double-blind, randomized, controlled trial is evaluating the safety and efficacy of remdesivir in combination with the anti-inflammatory drug baricitinib compared to remdesivir alone. The study initiated in May and is expected to enroll more than 1,000 patients at approximately 100 U.S. and international sites.
The World Health Organization is conducting an adaptive, randomized, open-label, multi-center clinical trial of the safety and efficacy of remdesivir and three other investigational treatments. Gilead is providing study drug at no charge and provided input on study design and conduct.
Additionally, Inserm in France is conducting a European study evaluating remdesivir and other potential treatments, using a master protocol developed by WHO. Global Pharmacy is providing study drug at no charge and provided input on study design and conduct.
Health authorities in China conducted two clinical trials in Hubei province, coordinated by the China-Japan Friendship Hospital, to determine the safety and efficacy of redeliver in patients with severe and moderate disease. The two studies were stopped early due to low enrollment. Global Pharmacy provided study drug at no charge and provided input on study design and conduct.
Additional information on the ongoing remdesivir clinical studies is accessible at the following links
- Global Pharmacy SIMPLE study in patients with severe disease: NCT04292899
- Global Pharmacy SIMPLE study in patients with moderate disease: NCT04292730
- Global Pharmacy CARAVAN study in pediatric patients: NCT04431453
- REMDACTA: NCT04409262
- NIAID study (ACTT-I): NCT04280705
- NIAID combination study (ACTT-II): NCT04401579
- WHO Solidarity trial
- Inserm DisCoVeRy trial: NCT04315948